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Curcumin (Diferuloylmethane Derivative) With or Without Bioperine in Patients With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00113841
Recruitment Status : Completed
First Posted : June 13, 2005
Results First Posted : October 19, 2011
Last Update Posted : November 23, 2011
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Curcumin
Drug: Bioperine
Enrollment 42
Recruitment Details Recruitment period: 11/2004 to 1/2008. All participants were recruited at UT MD Anderson Cancer Center.
Pre-assignment Details Of 42 patients enrolled, 9 were excluded from the trial prior to group assignment because of screen failure.
Arm/Group Title Curcumin Curcumin + Bioperine
Hide Arm/Group Description Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.) Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
Period Title: Overall Study
Started 16 17
Completed 15 15
Not Completed 1 2
Reason Not Completed
Disease progression             0             2
Non-compliant             1             0
Arm/Group Title Curcumin Curcumin + Bioperine Total
Hide Arm/Group Description Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.) Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily Total of all reporting groups
Overall Number of Baseline Participants 16 17 33
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants 17 participants 33 participants
59
(46 to 78)
62
(41 to 78)
59
(41 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
Female
6
  37.5%
5
  29.4%
11
  33.3%
Male
10
  62.5%
12
  70.6%
22
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 17 participants 33 participants
16 17 33
1.Primary Outcome
Title Percent Change of NF-kB Protein Expression in Peripheral Blood Mononuclear Cells From Baseline Through 4 Weeks of Treatment
Hide Description Percent change of NF-kB =[(expression at 4 weeks- expression at baseline)/expression at baseline]*100%. Bone marrow aspirate/biopsy for expression of NF-kB and related genes/proteins markers at baseline and after 4 weeks.
Time Frame Baseline through 4 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in the two arms (Curcumin versus Curcumin plus Bioperine) who received at least 4 weeks of treatment were eligible for outcome evaluation.
Arm/Group Title Curcumin Curcumin + Bioperine
Hide Arm/Group Description:
Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: Percent reduction
21  (37) 37  (25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Curcumin, Curcumin + Bioperine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 4 years and 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Curcumin Curcumin + Bioperine
Hide Arm/Group Description Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.) Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
All-Cause Mortality
Curcumin Curcumin + Bioperine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Curcumin Curcumin + Bioperine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Curcumin Curcumin + Bioperine
Affected / at Risk (%) Affected / at Risk (%)
Total   9/16 (56.25%)   9/17 (52.94%) 
Eye disorders     
Burning in the eyes  1  0/16 (0.00%)  1/17 (5.88%) 
Redness of eyes  1  0/16 (0.00%)  1/17 (5.88%) 
Watering eyes  1  1/16 (6.25%)  0/17 (0.00%) 
Gastrointestinal disorders     
Appetite decreased  1  0/16 (0.00%)  1/17 (5.88%) 
Constipation  1  2/16 (12.50%)  2/17 (11.76%) 
Diarrhea  1  1/16 (6.25%)  0/17 (0.00%) 
Feeling of fullness with capsules  1  0/16 (0.00%)  2/17 (11.76%) 
Flatulence  1  1/16 (6.25%)  2/17 (11.76%) 
Indigestion  1  1/16 (6.25%)  0/17 (0.00%) 
Queasy feeling  1  1/16 (6.25%)  0/17 (0.00%) 
Nausea  1  1/16 (6.25%)  0/17 (0.00%) 
General disorders     
Flushing  1  2/16 (12.50%)  0/17 (0.00%) 
Headache  1  2/16 (12.50%)  4/17 (23.53%) 
Yellow discoloration of finger tips  1  2/16 (12.50%)  0/17 (0.00%) 
Yellow discoloration of sweat  1  1/16 (6.25%)  0/17 (0.00%) 
Yellow discoloration of urine  1  1/16 (6.25%)  1/17 (5.88%) 
Musculoskeletal and connective tissue disorders     
Muscle pain  1  1/16 (6.25%)  1/17 (5.88%) 
Pain  1  1/16 (6.25%)  0/17 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chest discomfort  1  1/16 (6.25%)  0/17 (0.00%) 
Dyspnea  1  1/16 (6.25%)  0/17 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Saroj Vadhan-Raj, MD/Professor
Organization: UT MD Anderson Cancer Center
Phone: 713-792-9660
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00113841     History of Changes
Other Study ID Numbers: 2003-0436
First Submitted: June 10, 2005
First Posted: June 13, 2005
Results First Submitted: September 13, 2011
Results First Posted: October 19, 2011
Last Update Posted: November 23, 2011